BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHORESOR II

    MDR report key: 284296 · Received July 1, 2000

    Report

    Report Number
    284296
    Event Type
    Other
    Date Received
    July 1, 2000
    Date of Event
    May 17, 2000
    Report Date
    June 29, 2000
    Manufacturer
    IOMED
    Product Code
    EGJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A BURN UNDER DISPERSIVE PAD ON THE UPPER RIGHT FOREARM - SIZE OF A PEA - LIGHT BROWN IN COLOR. PRODUCT PROBLEM - PAD USED WITH IONTOPHORESIS MACHINE. BRAND OF PAD UNKNOWN. IT'S NOT LABELED OR MARKED. IN CHECKING THE PAD, IT WAS IDENTIFIED BY CLINICAL ENGINEERING TO BE WORN AND HAS BEEN TAKEN OUT OF SERVICE. ONLY THE BRAND MACHINE IS LABELED AS STATED IN SECTION D. THIS EQUIPMENT IS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHORESOR II IONTOPHORESIS DISPERSIVE PAD EGJ IOMED PM700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other